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There are high hopes for this vaccine.
© APA (AFP)
The US Food and Drug Administration (FDA) granted emergency approval to the corona vaccine from Mainz-based pharmaceutical company BioNTech and its US partner Pfizer. The companies submitted the corresponding application to the FDA in November. They were the first Western manufacturers to apply for emergency approval from the FDA. The still president of the United States, Donald Trump, promised his compatriots the first vaccines this weekend.
“The first vaccine will be administered in less than 24 hours,” Trump announced in a video Friday night (local time) on Twitter. His government has already started shipping the vaccine from Mainz-based pharmaceutical company BioNTtech and American company Pfizer to every state in the US Their governors would decide who would get the vaccines there first.
Trump emphasized that vaccines are free for all Americans. Watching the vaccine develop in record time, he said, “This is one of the greatest scientific achievements in history.” The vaccine will save millions of lives “and end the pandemic once and for all.” Trump presented the development as a success for his administration, which is not true. The president said, “The pandemic may have started in China, but we are ending it right here in the United States.”
An application has also been submitted to the European Medicines Agency (Ema) for the approval of the corona vaccine in the EU, a decision on this is still pending. In early December, the UK Pharmaceuticals Regulatory Authority granted emergency preparation approval for BioNTech / Pfizer. Britain became the first state in the world to approve the vaccine. Meanwhile, Canada, Bahrain and Saudi Arabia, among others, have approved the vaccine.
The so-called Pfizer / BioNTech mRNA vaccine is about 95 percent effective after an extensive series of tests, as the manufacturers had announced. This means that 95 percent fewer illnesses occurred among subjects in the vaccinated group than among subjects in the control group. The study has now also been published in the renowned “New England Journal of Medicine” (NEJM).
According to the manufacturer, the vaccine works equally well in all age groups and other demographic differences and shows virtually no serious side effects. The tests had examined protection against Covid 19 disease.
Conditional approval, as is now the case for the BioNTech vaccine, is intended to meet urgent medical needs. Applicants may obtain conditional approval in the interest of public health if the benefits outweigh the risk posed by less data than is normally required. Missing data, for example on long-term efficacy or on certain subgroups, should be submitted as soon as possible.
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